Regulatory Focus™ > News Articles > Regulatory Reconnaissance (10 December 2012)

Regulatory Reconnaissance (10 December 2012)

Posted 10 December 2012 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include: The Supreme Court of the US will take up a challenge against pay-for-delay legal agreements, a long-time FDA director retires, device manufacturers get a small reprieve in the implementation of the device tax, FDA implements a USP policy on labeling heparin, AstraZeneca loses a EU court case on delaying its completion, India wants tighter restrictions on antibiotics, and Pfizer loses close to a million dollars in gold.

United States

(Pharmalot) The US Supreme Court will review the pharmaceutical industry practice of pay-for-delay, the court precedence of which has been both volatile and varied. Government regulators, most notably the Federal Trade Commission (FTC), have called the deals anti-competitive.

(Pharmalot) Ed Silverman reports that FDA's Tom Laughren, director of the Division of Psychiatry Products, Office of New Drugs, has retired after 20 years with the agency. Biocentury meanwhile reports that Mitchell Mathis is serving as acting director. (BioCentury)

(NY Times) Mylan is suing FDA in an attempt to get the agency to revoke Ranbaxy's exclusivity license to market the generic version of Novartis' Diovan, a blood pressure drug, reports The Times. At issue is FDA's final approval of the generic version of Ranbaxy's version of the drug, which normally must occur within 30 months of the company's patent challenge. Ranbaxy missed the deadline, and Mylan argues it did not have sufficient reason to do so.

(Scientific American) Is FDA to blame for the dearth of new antibiotic therapies? Some critics think so, and now signs are emerging that the agency is willing to reconsider its drug approval paradigm for antibiotics. Critics contend that the current model is too risk-averse, and is an over-reaction to prior safety failures.

(Genetic & Engineering News) With US dollars funding less of the costs of drug development since the 1970's, pharmaceutical companies are now in a position where they spend considerably more than the government when it comes to pharmaceutical R&D. The shift comes as companies have been accused of a myriad of publication biases when it comes to reporting the results of their clinical trials.

(FDA) Pain drug manufacturer Qualitest, a subsidiary of Endo Health Solutions, has voluntarily recalled additional lots of its generic Vicodin product, saying consumers could potentially receive higher-than recommended doses of acetaminophen.

(Mass Device) Medical Device companies will soon face the reckoning of a medical device excise tax passed into law along with the 2010 healthcare overhaul. Mass Device reports that while the tax is still set to come into effect, the Internal Revenue Service, the agency charged with collecting the tax funds, will be lenient in at least one area: late payments, but only through September 2013. Some Senators, meanwhile, are still searching for a pay-for to replace the tax while keeping revenues neutral. (Mass Device)

(PharmExec) Last week's monumental court decision on off-label marketing, the Caronia decision, has the potential to shake up a decades-old system of regulatory marketing enforcement. This PharmExec article explores the ramifications and limits of the decision.

(Fierce Medical Devices) Once medical devices are on the market, are they just as safe as when they were purchased? In at least one way, probably not: software security. Fierce Pharma rounds up the coverage on the hacking potential of medical devices, noting that many hospitals do not adequately protect their medical devices.

(Fierce Medical Device) An FDA panel has voted to keep Abiomed's Impella temporary ventricular support device registered under the Class III designation, meaning it will soon need to file a Premarket Application (PMA) with FDA. The devices currently operate under a 510(k) substantial equivalence license.

(Pharmalot) A recent California law that requires pharmaceutical companies to finance the costs of disposing of their medications has been challenged by pharmaceutical companies in court. The companies-represented-by trade groups PhRMA, GPhA and BIO-argue the law places too much of an onus on companies, when it should be a shared burden.

(Biocentury) FDA's Anesthetic and Analgesic Drug products Advisory Committee has overwhelmingly voted against approving Zogenix's Zohydro, a pure formulation of the drug hydrocodone bitartrate, citing its high potential for abuse.

(US PTO) The US Patent and Trademark Office (PTO) is highlighting a piece of proposed legislation it says could boost its "Patents for Humanity" program, which provides prize-based incentives for the application of products to "alleviate poverty and suffering" around the globe. The new legislation would make the prizes transferrable or able to be sold on the open market.

(FDA) Regulators have announced safety changes for formulations of heparin, modeled off of a US Pharmacopoeia proposal aimed at revising the labeling for heparin products to make them easier to understand by showing the total number of heparin units per container.

(SAMHSA) Health regulators have made changes to the federal opioid treatment program regulations by modifying the dispensing requirements for buprenorphine and buprenorphine combination products, allowing more flexibility in dispensing take-home supplies of the drug.

(FDA) FDA announced two meetings this week: Its Endocrinologic and Metabolic Drugs Advisory Committee, which will discuss Janssen's canagliflozin tablets for Type 2 diabetes, and its Cellular, Tissue and Gene Therapies Advisory Committee, which will hear general regulatory updates from FDA.

(NY Times) The prolific use of drugs in some animals-in this case, horses-is causing some countries to re-think the import of US-sourced meat products.


(EMA) EU regulators are reminding stakeholders about the requirements for future submissions using the electronic common technical document, which EMA says are required to use a new 4.1 format. Submissions using the 3.1 format will be accepted until 31 January 2013.

(European Commission) The health ministers of 27 EU countries have adopted a new voluntary action plan meant to improve the standards of quality and safety for donated human organs. Commissioners have also discussed a new public health framework for health security, the tenets of which strongly impact regulated healthcare products. (EC)

(PharmaBiz) Indian drug regulators are seeking to "rationalize" the use of antibiotics in the country by placing more drugs under a schedule system.

(Pharma Times) The British pharmaceutical trade association ABPI is stepping up in its efforts against the National institute for Health and Clinical Excellence (NICE), reports Pharma Times. The problem, as perceived by industry, is that the comparative effective research agency is failing to recognize small amounts of innovation, which ABPI argues is harming patients.

(Fierce Pharma) AstraZeneca has lost a case before the EU's top court after justices rules that the company's actions-and implicitly those of others as well- taken to protect the exclusivity of its drugs were anticompetitive.

(PharmAfrica) East Africa now has its first bioequivalence testing center, located in Ethiopia, reports PharmAfrica.

Interesting Reads

(Pharmalot) How do you lose close to a million dollars in gold dust? That's the question Pfizer is asking itself after nearly 30 pounds of the stuff, used in various research applications, went missing from a St. Louis, MO facility. (STL Today)

[Editor's note: Your Regulatory Focus news editor is at a regulatory conference today and tomorrow. Regular coverage will resume on Wednesday, 11 December.]

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